Lipid nanoparticles (LNPs) have transformed drug delivery for nucleic acid therapeutics, including mRNA, siRNA, DNA, and gene editing platforms. With more than a decade of hands-on experience in LNP development, we help pharmaceutical innovators design, optimize, and scale lipid-based drug products for preclinical, clinical, and commercial success.

From early formulation through GMP manufacturing, our consulting services provide strategic and technical support at every phase of LNP development—ensuring safety, stability, efficacy, and regulatory alignment.

Our LNP Development Services

1. LNP Formulation Design & Screening

We design and optimize LNP compositions to meet your therapeutic goals—whether for delivery of genetic payloads or small molecules.
Includes:

• Lipid selection (ionizable, PEGylated, helper, cholesterol)
• Component ratio optimization and screening
• Physicochemical property tuning (size, charge, PDI, encapsulation)
• Microfluidics, solvent injection, and turbulent flow mixing strategies

2. Preclinical Development & Characterization

Establish robust, reproducible LNP formulations with defined performance and quality.
Includes:

• In vitro characterization: size, zeta potential, encapsulation efficiency
• Stability studies and forced degradation profiles
• Payload release, cellular uptake, and transfection efficiency
• Process feasibility at small- and mid-scale

3. Process Development & Scale-Up for GMP

We help scale your LNP formulation to manufacturing levels under cGMP standards while preserving quality and performance.
Includes:

• Technology transfer to GMP/CDMO facilities
• Equipment selection and process optimization
• Batch reproducibility and process control strategies
• Filtration, sterilization, and filling compatibility

4. Regulatory & CMC Support

We ensure your LNP drug product development meets global regulatory expectations, including IND-enabling studies.
Includes:

• CMC documentation and formulation description
• Analytical method development and validation
• Regulatory strategy and FDA engagement
• IND support and stability protocols

Applications Supported

• mRNA and siRNA therapeutics
• Gene editing delivery (CRISPR-Cas9, base editors)
• Cancer immunotherapy and vaccines
• Rare disease and metabolic disorder treatments
• Protein and peptide payload encapsulation

Why Work With Us

• Proven success: LNP products developed and manufactured for clinical use in cancer and COVID-19
• Scientific depth: Decades of experience in formulation science, nanotechnology, and regulatory development
• End-to-end support: From bench to GMP, IND to commercialization
• Custom-tailored: Every LNP system is designed for your unique molecule and clinical goals

Build Next-Generation Therapeutics with Confidence

Whether you are designing your first LNP formulation or scaling toward commercialization, we offer the scientific, regulatory, and manufacturing insight to accelerate your success.

📧 Contact us to discuss your LNP drug product goals and how we can support your innovation.